Inhaled Antibiotic Used to Treat Cystic Fibrosis Shows Positive Results in Clinical Trials

April 23, 2007

Gilead Sciences, Inc. has announced positive results of a clinical trial evaluating the use of an antibiotic treatment for cystic fibrosis patients with pulmonary infections. Aztreonam lysine, an inhaled version of a similar antibiotic already approved by the Food and Drug Administration, was studied on CF patients with Pseudomonas aeruginosa pulmonary infections.

Results from a Phase 3 clinical trial involving 246 volunteers demonstrated that patients receiving a 28-day treatment of inhaled aztreonam lysine experienced significant improvements in pulmonary function and respiratory symptoms when compared to those receiving a placebo. Patients using inhaled aztreonam lysine also could go longer periods of time before needing to use additional inhaled or intravenous antibiotics.

Gilead expects to submit a New Drug Application for aztreonam lysine for inhalation in the second half of 2007. Data from this analysis has not yet been reviewed by the Food and Drug Administration.